BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3190286 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04360
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    IYO
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-04359 AND MDR ID# 2134265-2013-04361. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, THE SLED WOULD NOT MECHANICALLY PULLBACK. DURING AN IVUS PROCEDURE, IT WAS NOTED THAT THE SLED OF THE ILAB IMAGING SYSTEM WOULD NOT MECHANICALLY PULLBACK. THE PROCEDURE WAS COMPLETED WITH MANUAL PULLBACK. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291098 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR IYO BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1